As new technologies continue to emerge, transcatheter techniques have become part of the treatment armamentarium for cardiologists. They allow for a less invasive option for patients who were previously only treatable with open heart surgery or, in many cases, not treatable at all. Transcatheter mitral valve therapy, a procedure in which catheters are used to place clips on the mitral valve and reduce regurgitation, has emerged as the only alternative treatment to open heart surgery for patients with valvular heart disease, thus making it an essential option for high-risk individuals
In 2014, a committee of cardiac surgeons and interventional cardiologists from the American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, and the Society of Thoracic Surgeons developed a consensus paper that provides clinicians and hospitals guidance on developing and maintaining transcatheter mitral valve therapy programs for the first time. Published simultaneously in the Journal of the American College of Cardiology, Annals of Thoracic Surgery, and Catheterization & Cardiovascular Interventions, the document establishes core competencies and technical skills for providers and institutions.
“As transcatheter techniques are used more frequently, it’s important to establish and promote best practices and standards of care so that patients can have the best possible outcomes,” says Carl L. Tommaso, MD, FACC, who chaired the consensus writing committee. With the emergence of innovative devices and rapidly developing techniques, the qualifications to participate in transcatheter mitral valve therapy are unique. The field requires a combination of interventional skills, equipment, collaborative clinical management, surgical approaches, techniques, and careful patient selection.
Identifying Key Requisites
Given the high-risk nature of transcatheter techniques and the availability of established alternatives with traditional surgical approaches, several considerations are important for institutions and operators planning to implement these new technologies. The critical cornerstone of transcatheter valve programs is a formal, collaborative effort between interventional cardiologists and cardiac surgeons. The overarching goal of these programs must be to provide the best possible patient-centered care.
Defining operator and institutional requirements for transcatheter mitral valve programs is an important first step to ensuring their optimal implementation.The consensus paper outlines important details about the requirements for establishing a successful program (Table 1). From the institutional perspective, each facility is recommended to have an active valvular heart disease surgical program with at least two institutionally based cardiac surgeons who are experienced in valvular surgery. Institutions should also have a full range of diagnostic imaging and therapeutic facilities available (Table 2).
A Multidisciplinary Approach
Throughout the recommendations, a need for a multidisciplinary team (MDT) approach is emphasized. With MDTs, surgeons and interventional cardiologists with extensive knowledge and diagnostic skills related to valvular disease are involved throughout the course of care along with other key caregivers. “To establish an effective transcatheter valve program, a joint effort will be needed that is backed by the institution and involves everyone from interventional cardiologists and cardiac surgeons to nurses, dieticians, and other specialists that will be involved in patient care,” says Dr. Tommaso. “This is essential because no single person, group, or specialty possesses all the necessary skills for the best patient outcomes.”
Since the specialties that provide some of the key components of care will vary from program to program, it is recommended that comprehensive MDT programs be in place for transcatheter valve therapies and structural interventional programs. Regardless of their specialty, operators should have a thorough understanding of valvular heart disease and have the ability to interpret echocardiographic and other radiographic images. “MDTs can set the standard of care for improving patient treatment and outcomes by building and maintaining quality programs,” Dr. Tommaso says.
A National Registry
The consensus document also advocates for long-term outcomes reports and participation in data registries. “It should be mandatory for existing and new transcatheter programs to participate in these registries so that we can ensure accurate data collection on survival and complications,” says Dr. Tommaso. “Participation will also help clinicians determine the risk and long-term durability of devices, which is especially important with the likely introduction of new technologies in the future.” He notes that transcatheter valve repair or replacement devices are unique because clinicians are still gaining a better understanding of the appropriate patient groups for these therapies.
As experience grows and more data become available, these recommendations are expected to be refined. “Novel treatments and techniques are continuing to evolve, but we’re also still learning about the safety and efficacy of current devices as well as ideal candidates for them,” Dr. Tommaso says. “As this information emerges, it will be critical for professional associations to continue to champion quality improvement efforts for all providers, keeping in mind the best interest of patients.”
Readings & Resources (click to view)
Tommaso CL, Cigarroa JE, Fullerton D, et al. SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement, part II–mitral valve. J Am Coll Cardiol. 2014 May 14 [Epub ahead of print]. Available at: http://content.onlinejacc.org/article.aspx?articleid=1872608.
Herrmann HC, Baxter S, Ruiz CE, Feldman TE, Hijazi Z. Results of the Society for Cardiac Angiography and interventions survey of physicians and training directors on procedures for structural and valvular heart disease. Cathet Cardivasc Interevnt. 2010;e106-e110.
Bashore TM, Balter S, Barac A, et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: a report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012;59:2221-2305.
Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010;304:1693-1700.
Feldman T, Foster E, Glower DG, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364:1395-1406.